1 April 2015
Review of Medicines and Medical Devices Regulation Secretariat
Department of Health
MDP 67
GPO Box 9848
CANBERRA ACT 2601
medicines.review@health.gov.au
Dear Emeritus Professor Lloyd Sansom AO
Re: Review of Medicines and Medical Devices Regulation Chapter Nine: Regulation of
Complementary Medicines
Thank you for the opportunity to respond to the current review of regulation of complementary
medicines. The Federation of Chinese Medicine & Acupuncture Societies of Australia Ltd
(FCMA) is a national Chinese medicine association and has more than 700 Chinese medicine
practitioners in all states and territories. As a President of and a Chinese medicine practitioner, I
represent the interest of our Chinese herbal medicine practitioners and would therefore like to
respond solely from the perspective of Chinese herbal medicine practice.
Chinese medicine is recognised as a medical practice by the World Health Organization (WHO).
Chinese herbal medicine practice differs from complementary medicines such as homeopathy,
naturopathy and aromatherapy.
The World Federation of Chinese Medicine Societies (WFCMS) which is comprised of159 member
countries and districts and the world’s largest and foremost authority on Chinese medicine, recently
signed an agreement with the WHO as a cooperating Working Party for Chinese Medicine
including the setting of international standards in Chinese Medicine. The FCMA, a member of the
WFCMS will represent Australia on this Working Party and will be in charge of the Oceania zone.
After reviewing Chapter Nine: Regulation of Complementary Medicines, on behalf of the FCMA, I
would like to make the following recommendations; after which I provide our rationale for the
same.
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Recommendations
Due to the fact that Chinese medicine profession is nationally regulated via statutory regulation, the
FCMA recommends that:
1. A separate committee be established solely for Chinese herbal medicines;
2. A different set of criteria be established for the importation of Chinese herbal products;
3. A different set of criteria be established for the evaluation of the level of risk and toxicity of
the Chinese herbal medicines.
Rationale
Recommendation 1: A separate committee be established solely for Chinese herbal medicines
The FCMA believes that a separate “Chinese Materia Medica Expert” committee/panel to deal
solely with Chinese herbal products would be more appropriate than a blanket committee to
evaluate the safety of herbal products. While members of more general committees associated with
Complementary and Alternative Medicine are generally familiar with western pharmaceuticals, they
may not be familiar with Chinese herbal products. This is due to the unique way by which the
products are understood to work and are used. In western pharmaceutics, the medicines are
extremely highly concentrated with one active substance made either by extraction from a natural
product or made synthetically. Therefore, these substances are extremely potent and in some cases,
potentially lethal. Chinese herbal medicines are prepared either by extraction from whole natural
herbs into decoctions, or finely grounded and compacted into patent pills, freeze dried as a
powdered single herb or extracted commercially as a single liquid herbs. Whether herbs used
singly or in a formulation, single active substances are not isolated and they contain all the
substances from the plant, therefore the herbs are neither highly concentrated nor as potent
compared to Western pharmaceuticals.
An example of the lack of full appreciation by regulatory bodies regarding the different methods in
the use of whole herbs and single isolated substances could be seen in the potency of a
plant/pharmaceutical product, Ma Huang (Ephedra used as ephedrine). Ephedra as a plant has been
used in in Chinese medicine for 2000 years (noted in ancient medical texts) and its effects and side
effects were already noted with a known antidote. Even as a raw herb, Chinese medicine
practitioners are aware of the dosage not to be exceeded for treatments. In Western pharmaceutical
use, only the active substance (ephedrine) is extracted and the concentrated form is noted to very
potent and potentially lethal. For this reason, ephedra, a substance currently listed on Schedule 4 of
the Poisons Standard 2015, is banned from use by Chinese medicine practitioners. This is a clear
lack of understanding by a Committee attempting to regulate another profession/s.
We also believe that a committee to evaluate, say, naturopathy or homeopathy is still inappropriate
as these complementary medicine practices generally use extracted single substances rather than
whole herbs (in the case of homoeopathy, the amounts are below Avogadro’s number in terms of
amount of the substance in the homoeopathic formulation).
For the above reasons we suggest that a committee/panel to be made up of the following experts:
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Specialist/s in Chinese materia medica
Specialist/s in Chinese patent products
Chinese medicine practitioner/s
Representation from Chinese medicine association/s
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Relevant members from the Therapeutic Goods Authority (TGA) or representatives from
their complimentary medicine review committee.
A consumer representative or advocate
Other members as deemed necessary
During the 1990’s the FCMA was the key association involved in the review of regulation of
Chinese medicine profession which ultimately led to the registration of Chinese medicine practice
in the state of Victoria. During the earlier years, I was personally involved in the review of herbal
products for importation into Australia. The FCMA would be pleased to be of assistance to the
Office of Complementary Medicines.
Recommendation 2: A different set of criteria be established for the importation of Chinese herbal
products
The FCMA believes that products imported into Australia should be of good quality and safe for
use. We suggest that the TGA collaborate with the State Administration of Traditional Chinese
Medicine of China (SATCM) to establish a specific set of criteria in relation to importation of
proprietary forms of Chinese medicines. Regarding safety, we agree that for products that are
manufactured, compliance with Good Manufacturing Practice (GMP) is mandatory.
With respect to raw herbs, these are currently screened by Australian Customs and the Australian
Quarantine Inspection Service (AQIS) and fall outside the jurisdiction of the TGA which handles
only proprietary forms of complementary medicines. It is suggested that regulation of the safety and
quality of raw herbs be integrated under one jurisdiction that is, combined with proprietary forms of
Chinese herbal medicines.
Recommendation 3: A different set of criteria to be established for the evaluation of the level of risk
and toxicity of Chinese herbal medicines
The FCMA is concerned with the current way in which some Chinese herbal medicines are
scheduled and regulated, in that it restricts the availability of the range of products that could be
used by Chinese medicine practitioners even though all Chinese herbal medicine practitioners have
been registered under the Australian Health Practitioner Regulation Agency (AHPRA). These
restrictions affect the efficacy and efficiency of treatments given to those seeking assistance.
Due to the concept of food as medicine and medicine as food, we consider the current rescheduling
of foods to be problematic for Chinese herbal practice. Chinese herbal practice uses most products
in their natural state. Many of the natural ingredients are normal food products which could be
brought from Asian grocery stores such as Hong Qu (Red Yeast Rice). While these are considered
safe to the general public, the TGA has banned their use by Chinese medicine practitioners. It
makes no sense that while the public who has no knowledge of the medicinal use and safe dosages
of these substances are given full access, Chinese medicine practitioners who have the knowledge
are not given access. Red yeast rice is frequently used in general cooking and to enhance the flavor
of food by chefs. These ingredients are safer in the hands of practitioners because of the controlled
dosages being dispensed. Isolated constituents of herbs that could be potentially toxic in
concentrated forms as used in western pharmaceuticals, may be no more toxic than foods when
consumed at appropriate dosages in their natural form. Importantly when any single herbal product
or formulations of several herbs are dispensed, Chinese herbal medicine practitioners are
knowledgeable in the dosages to be used; therefore such herbs are already safer in the hands of
practitioners than when used by the general public as foods. It makes little sense to ban
practitioners from using herbs when dosages for dispensing are controlled. For this reason, we
believe that it is necessary for a different set of criteria to be established for scheduling of Chinese
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herbal medicines. This illustration equates to, for example, Panadol being easily accessible to the
public via supermarkets, yet, doctors not being allowed to prescribe it.
It is for the above reasons that we recommend that a separate and dedicated committee be set up to
develop criteria appropriate and relevant to the way Chinese herbal medicines are used. This would
mean that the current rescheduling of Chinese herbal medicines from Schedule 4 to Schedule 9 and
the Appendixes of the Poisons Standard would be reviewed with renewed understanding of the
safety of the herbs.
With regard to products that could be potentially toxic, consultation with a committee of experts in
Chinese herbal pharmacopeia and collaboration with similar authorities overseas like the State
Administration of Traditional Chinese Medicine of China (SATCM) or the World Federation of
Chinese Medicine Societies (WFCMS), would be of much assistance and desirable.
We hope that you would kindly consider this submission. Please feel free to contact me if any for
any more information is required.
Yours Sincerely,
Prof. Tzi Chiang Lin, PhD.
National President, FCMA.
Prepared by:
Prof. Tzi Chiang Lin
Dr. Grace Tham
Private Health Funds Liaison Officer, FCMA
Dr. Sherman Gu,
Officer, FCMA
Associate Professor Kylie O’Brien
Vice-President Victorian branch, FCMA
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